Lumbar Spinal StenosisNCT07445477
Erector Spinae Plane vs Caudal Epidural Steroid in Lumbar Spinal Stenosis Resistant to Conservative Therapy
A study testing Erector Spinae Plane Block and caudal epidural steroid injection in people with Lumbar Spinal Stenosis, run by Hatice Çetintürk Şahin at 1 site in Turkey (Türkiye).
Trial summary
Lumbar spinal stenosis is a common cause of neurogenic claudication and functional limitation in older adults. Epidural steroid injections are frequently used in patients who do not respond to conservative treatments. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Erector Spinae Plane Block and caudal epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2024to 10 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 80 years
- Patients with chronic low back pain (lasting longer than 6 months)
- Diagnosis of lumbar spinal stenosis (LSS) confirmed by imaging modalities (CT/MRI) and clinical evaluation
- LSS Diagnostic Support Tool Assessment (LSS-DST) score greater than 7
- Patients who did not benefit from previous conservative treatments
- Presence of a signed written informed consent form indicating willingness to participate in the study
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- LSS-DST (Lumbar Spinal Stenosis - Diagnostic Support Tool) Scoring System
- Age 60-70 years: +1 point
- Age over 70 years: +2 points
- Absence of Diabetes Mellitus: +1 point
- Positive claudication: +3 points
- Symptoms aggravated by standing: +2 points
- Symptoms relieved by forward flexion: +3 points
- Symptoms induced by forward flexion: -1 point
- Symptoms induced by lumbar extension: +1 point
- Ankle-brachial index ≥ 0.9: +3 points
- Abnormal Achilles tendon reflex: +1 point
- Positive straight leg raise test: -2 points
Who cannot join
- History of lumbar epidural steroid injection within the last 6 months or history of major trauma
- Known allergy to the study medications (lidocaine hydrochloride, dexamethasone 21-phosphate) or to contrast agents
- Presence of unstable chronic medical conditions (e.g., diabetes mellitus, hypertension, chronic obstructive pulmonary disease, heart failure)
- Advanced joint limitations preventing mobilization (e.g., hip or knee osteoarthritis)
- History of previous lumbar spine surgery
- Current anticoagulant therapy or history of coagulopathy
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- History of malignancy
- History of polyneuropathy
- Presence of peripheral vascular disease
- Psychiatric disorders or cognitive impairment that would interfere with completion of questionnaires and assessment scales (including significant visual or hearing impairment)
- Presence of local or systemic infection at the intended injection site
- Pregnancy and/or breastfeeding
- Refusal or inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gaziler Physical Medicine and Rehabilitation Training and Research Hospital
Ankara
About this study
Official title: A Prospective Comparative Study Evaluating the Effectiveness of Erector Spinae Plane Block Versus Caudal Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis Refractory to Conservative Treatment
Lumbar spinal stenosis is a common cause of neurogenic claudication and functional limitation in older adults. Epidural steroid injections are frequently used in patients who do not respond to conservative treatments. The erector spinae plane block has recently emerged as a potential alternative interventional technique for pain control in lumbar spine disorders.
This prospective comparative study will evaluate and compare the effectiveness of erector spinae plane block and caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment. Clinical outcomes including pain intensity, functional status, and walking capacity will be assessed at predefined follow-up intervals.
The study aims to determine whether erector spinae plane block provides comparable or superior clinical benefit compared with caudal epidural steroid injection in this patient population.
Read the detailed description
This prospective, randomized, parallel-group comparative study was conducted to evaluate the clinical effectiveness of ultrasound-guided lumbar erector spinae plane block compared with fluoroscopy-guided caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment.
Eligible participants were randomized into two intervention arms. Patients in the erector spinae plane block group received a lumbar 4 level ultrasound-guided injection of local anesthetic administered under sterile conditions. Patients in the caudal epidural steroid injection group received a fluoroscopy-guided caudal epidural injection consisting of corticosteroid and local anesthetic according to institutional protocol.
The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS) for leg pain. Assessments were performed before the procedure, 1 hour after injection, and at 4 and 8 weeks following the intervention.
Secondary clinical evaluations included functional status and walking capacity assessed at predefined follow-up intervals.
The study was approved by the local ethics committee, and written informed consent was obtained from all participants prior to enrollment.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Erector Spinae Plane Block, caudal epidural steroid injection
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Ultrasound-guided erector spinae plane block performed at the lumbar level using local anesthetic under sterile conditions.
caudal epidural steroid injectionProcedure or surgery
Caudal epidural steroid injection performed under sterile conditions using fluoroscopy according to institutional protocol.
| Study group | Role | What they receive |
|---|---|---|
| erector spinae plane block | Active comparator | Participants randomized to this arm received an ultrasound-guided lumbar erector spinae plane block with corticosteroid and local anesthetic for the treatment of lumbar spinal stenosis-related pain. Receives: Procedure: Erector Spinae Plane Block |
| caudal epidural steroid injection | Active comparator | Participants randomized to this arm received a fluoroscopy-guided caudal epidural steroid injection with corticosteroid and local anesthetic for the treatment of lumbar spinal stenosis-related pain. Receives: Procedure: caudal epidural steroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) for Leg Pain
Visual Analog Scale (VAS) for leg pain measured on a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Measured: Before injection; 1 hour after injection; 4 weeks after injection; 8 weeks after injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start10 Oct 2024
- Primary completion10 Jan 2026
- Study completion10 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hatice Çetintürk Şahin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Çetintürk Şahin, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
- Investigators
- hatice çetintürk şahin, Principal investigator, Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445477
- Sponsor's protocol ID
- 2024/1009
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.
PubMed 23615883Azevedo AS, Silva VTG, Xavier AL, da Silva LFF, Hojaij FC, Ashmawi HA, Vieira JE, Fernandes HS. Comparison of different injection volumes on spread of lumbar erector spinae plane block: An anatomical study. J Clin Anesth. 2021 Sep;72:110268. doi: 10.1016/j.jclinane.2021.110268. Epub 2021 Apr 10. No abstract available.
PubMed 33848824
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparative Study Evaluating the Effectiveness of Erector Spinae Plane Block Versus Caudal Epidural Steroid Injection in Patients With Lumbar Spinal Stenosis Refractory to Conservative Treatment
- ClinicalTrials.gov ID
- NCT07445477
- Acronym / sponsor ID
- 2024/1009
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hatice Çetintürk ŞahinUniversity, hospital or other
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Feb 2026 (actual)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lumbar spinal stenosis is a common cause of neurogenic claudication and functional limitation in older adults. Epidural steroid injections are frequently used in patients who do not respond to conservative treatments. The erector spinae plane block has recently emerged as a potential alternative interventional technique for pain control in lumbar spine disorders.
This prospective comparative study will evaluate and compare the effectiveness of erector spinae plane block and caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment. Clinical outcomes including pain intensity, functional status, and walking capacity will be assessed at predefined follow-up intervals.
The study aims to determine whether erector spinae plane block provides comparable or superior clinical benefit compared with caudal epidural steroid injection in this patient population.
Detailed description
This prospective, randomized, parallel-group comparative study was conducted to evaluate the clinical effectiveness of ultrasound-guided lumbar erector spinae plane block compared with fluoroscopy-guided caudal epidural steroid injection in patients with lumbar spinal stenosis refractory to conservative treatment.
Eligible participants were randomized into two intervention arms. Patients in the erector spinae plane block group received a lumbar 4 level ultrasound-guided injection of local anesthetic administered under sterile conditions. Patients in the caudal epidural steroid injection group received a fluoroscopy-guided caudal epidural injection consisting of corticosteroid and local anesthetic according to institutional protocol.
The primary outcome measure was pain intensity assessed using the Visual Analog Scale (VAS) for leg pain. Assessments were performed before the procedure, 1 hour after injection, and at 4 and 8 weeks following the intervention.
Secondary clinical evaluations included functional status and walking capacity assessed at predefined follow-up intervals.
The study was approved by the local ethics committee, and written informed consent was obtained from all participants prior to enrollment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erector spinae plane block | Active comparator | Procedure: Erector Spinae Plane BlockParticipants randomized to this arm received an ultrasound-guided lumbar erector spinae plane block with corticosteroid and local anesthetic for the treatment of lumbar spinal stenosis-related pain. |
| caudal epidural steroid injection | Active comparator | Procedure: caudal epidural steroid injectionParticipants randomized to this arm received a fluoroscopy-guided caudal epidural steroid injection with corticosteroid and local anesthetic for the treatment of lumbar spinal stenosis-related pain. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age between 30 and 80 years
- Patients with chronic low back pain (lasting longer than 6 months)
- Diagnosis of lumbar spinal stenosis (LSS) confirmed by imaging modalities (CT/MRI) and clinical evaluation
- LSS Diagnostic Support Tool Assessment (LSS-DST) score greater than 7
- Patients who did not benefit from previous conservative treatments
Key exclusion criteria (13 listed)
- History of lumbar epidural steroid injection within the last 6 months or history of major trauma
- Known allergy to the study medications (lidocaine hydrochloride, dexamethasone 21-phosphate) or to contrast agents
- Presence of unstable chronic medical conditions (e.g., diabetes mellitus, hypertension, chronic obstructive pulmonary disease, heart failure)
- Advanced joint limitations preventing mobilization (e.g., hip or knee osteoarthritis)
- History of previous lumbar spine surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockUltrasound-guided erector spinae plane block performed at the lumbar level using local anesthetic under sterile conditions. | Procedure or surgery | erector spinae plane block |
| caudal epidural steroid injectionCaudal epidural steroid injection performed under sterile conditions using fluoroscopy according to institutional protocol. | Procedure or surgery | caudal epidural steroid injection |
Primary outcome
Visual Analog Scale (VAS) for Leg Pain
Time frame: Before injection; 1 hour after injection; 4 weeks after injection; 8 weeks after injection.
Visual Analog Scale (VAS) for leg pain measured on a 0-10 numeric rating scale, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 23615883Manchikanti L, Abdi S, Atluri S, Benyamin RM, Boswell MV, Buenaventura RM, Bryce DA, Burks PA, Caraway DL, Calodney AK, Cash KA, Christo PJ, Cohen SP, Colson J, Conn A, Cordner H, Coubarous S, Datta S, Deer TR, Diwan S, Falco FJ, Fellows B, Geffert S, Grider JS, Gupta S, Hameed H, Hameed M, Hansen H, Helm S 2nd, Janata JW, Justiz R, Kaye AD, Lee M, Manchikanti KN, McManus CD, Onyewu O, Parr AT, Patel VB, Racz GB, Sehgal N, Sharma ML, Simopoulos TT, Singh V, Smith HS, Snook LT, Swicegood JR, Vallejo R, Ward SP, Wargo BW, Zhu J, Hirsch JA. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013 Apr;16(2 Suppl):S49-283.
- Background: PubMed 33848824Azevedo AS, Silva VTG, Xavier AL, da Silva LFF, Hojaij FC, Ashmawi HA, Vieira JE, Fernandes HS. Comparison of different injection volumes on spread of lumbar erector spinae plane block: An anatomical study. J Clin Anesth. 2021 Sep;72:110268. doi: 10.1016/j.jclinane.2021.110268. Epub 2021 Apr 10. No abstract available.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
hatice çetintürk şahin principal investigator
Gaziler Physical Medicine and Rehabilitation Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and caudal epidural steroid injection in people with Lumbar Spinal Stenosis, run by Hatice Çetintürk Şahin at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) for Leg Pain (time frame: Before injection; 1 hour after injection; 4 weeks after injection; 8 weeks after injection.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445477, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.